US9901299B2 - Activating functional electrical stimulation of abdominal muscles to assist coughing - Google Patents

Activating functional electrical stimulation of abdominal muscles to assist coughing Download PDF

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US9901299B2
US9901299B2 US15/102,588 US201415102588A US9901299B2 US 9901299 B2 US9901299 B2 US 9901299B2 US 201415102588 A US201415102588 A US 201415102588A US 9901299 B2 US9901299 B2 US 9901299B2
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fes
patient
glottis
signal
cough
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US20160310068A1 (en
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Lior Haviv
Noam Sobel
Amiram CATZ
Itzhak GLASS
Anton Plotkin
Aharon Weissbrod
Sagit SHUSHAN
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Mor Research Applications Ltd
Yeda Research and Development Co Ltd
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Mor Research Applications Ltd
Yeda Research and Development Co Ltd
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Assigned to MOR RESEARCH APPLICATIONS LTD. reassignment MOR RESEARCH APPLICATIONS LTD. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: GLASS, Itzhak, CATZ, Amiram
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    • G06F3/01—Input arrangements or combined input and output arrangements for interaction between user and computer
    • G06F3/011—Arrangements for interaction with the human body, e.g. for user immersion in virtual reality
    • G06F3/012—Head tracking input arrangements

Definitions

  • the present invention in some embodiments thereof, relates to methods and systems for using nasal airflow to activate Functional Electrical Stimulation (FES) of abdominal muscles to assist coughing.
  • FES Functional Electrical Stimulation
  • Tetraplegic patients cannot cough enough to clear their sputum because of expiratory muscle weakness, mainly of the abdominal muscles. This inability to cough may cause respiratory complications, such as pneumonia and atelectasis, and are major causes of mortality and inhibit rehabilitation programs in spinal cord injury. People with tetraplegia depend on a caregiver applying manual pressure intermittently to the anterior abdominal wall in order to induce assisted coughing.
  • FES Functional Electrical Stimulation
  • Patients who need assistance with coughing such as patients whose abdominal muscles may not be under their full control, can benefit from FES of the abdominal muscles to assist coughing, for example to clear their airways.
  • a patient uses nasal airflow to control initiation of FES of the abdominal muscles to assist coughing.
  • a patient's nasal airflow is monitored, and nasal airflow typical of an oncoming cough may be used to control initiation of FES of the abdominal muscles to assist the oncoming cough.
  • a system for assisted coughing including a first sensor for measuring a parameter which can indicate a closed glottis and producing a first signal, a processor for receiving the first signal, determine a state indicating the closed glottis and generating an instruction for a Functional Electric Stimulation (FES) controller based, at least in part, on the determining, and a FES controller for generating an electric stimulation signal.
  • FES Functional Electric Stimulation
  • the processor is further configured for detecting a command input, and to attempt to determine the state indicating the closed glottis following the command input.
  • the first sensor includes a nasal air sensor configured for sensing the patient's nasal air flow.
  • the second sensor is configured to accept the command input from a patient. According to some embodiments of the invention, the second sensor is configured to accept the command input from a caregiver.
  • the second sensor includes the same nasal air sensor configured for sensing the patient's nasal air flow.
  • the second sensor includes at least one patient command sensor selected from a group including an eye blink sensor, a microphone, an electromyography (EMG) electrode configured for sensing the patient's EMG activity of the neck muscles, a chest belt for monitoring respiration, and an electrophysiological sensor for sensing abdominal muscles.
  • EMG electromyography
  • the processor is configured to analyze the first signal from the nasal air sensor and generate the instruction for the FES controller based, at least in part, on the analysis.
  • the processor determines a state of closure of a glottis based, at least in part, on detecting a start of a plateau in the nasal air signal.
  • the processor produces the instruction for the FES controller when the processor detects a slope in the nasal air signal followed by a plateau in the nasal air signal, the plateau lasting at least 50 milliseconds.
  • the plateau is detected by the processor continuously sampling the nasal air signal and detecting a difference between nasal air signal values within the plateau of less than a threshold value.
  • the slope is fitted to a straight line having a slope ⁇
  • the plateau is fitted to a straight line having a slope ⁇
  • a value of a is below a threshold T ⁇
  • a value of ⁇ is below a threshold T ⁇
  • ⁇ and ⁇ are calculated as follows
  • r xy is a sample correlation coefficient between x and y
  • s x is a standard deviation of x
  • s y is a standard deviation of y
  • a horizontal bar over a variable denotes a sample average of the variable
  • the electric stimulation signal includes a same electric stimulation signal to all electrodes receiving the electric stimulation signal.
  • the electric stimulation signal includes a stimulation signal with a frequency of approximately 100 Hz, including pulse durations of 200 ⁇ s.
  • the electric stimulation signal includes a stimulation signal with a frequency in a range of 30 Hz-200 Hz, including pulse durations of 100 ⁇ s-300 ⁇ s.
  • the electric stimulation signal lasts for a period of time in a range of 250 milliseconds to 1250 milliseconds.
  • circuitry for adjusting the FES further including circuitry for adjusting the FES.
  • the unit for adjusting the FES adjusts a time of starting the FES. According to some embodiments of the invention, the unit for adjusting the FES adjusts a duration of the FES.
  • the adjusting the FES includes using feedback to automatically adjust the FES.
  • the feedback includes a value of at least one parameter selected from a group consisting of a value assigned to the patient's feedback, a value assigned to a medical practitioner' feedback, a value of air flow temperature during a cough which is assisted by the FES, a value of CO 2 concentration during a cough which is assisted by the FES, a value of electromyography (EMG) measured during a cough which is assisted by the FES, a value of PEF (Peak Expiratory Flow) of a cough which is assisted by the FES, a value of maximum nasal expiration during the cough which is assisted by the FES, a value of a maximum volume of a sound of the cough which is assisted by the FES, and a value maximum output of lung air of the cough which is assisted by the FES.
  • EMG electromyography
  • the adjusting the FES includes using machine learning to adjust the FES.
  • a method of assisted coughing including determining when a patient's glottis is expected to be closed, and producing Functional Electric Stimulation (FES) based, at least in part, on the determining.
  • FES Functional Electric Stimulation
  • the determining when the patient's glottis is expected to be closed is based, at least in part, on analyzing a signal from a sensor configured to sense a patient.
  • the determining when the patient's glottis is expected to be closed is based, at least in part, on analyzing a nasal air signal from a patient's nasal air flow sensor.
  • the determining when the patient's glottis is expected to be closed is based, at least in part, on determining a start of a plateau in the nasal air signal.
  • the determining when the patient's glottis is expected to be closed is based, at least in part, on determining a negative slope in the nasal air signal followed by determining a plateau in the nasal air signal, the plateau lasting at least 50 milliseconds.
  • the determining the plateau is performed by continuously sampling the nasal air signal and determining a difference of less than a threshold value between nasal air signal values within the plateau.
  • the negative slope is fitted to a straight line having a slope ⁇
  • the plateau is fitted to a straight line having a slope ⁇
  • a value of ⁇ is below a threshold T ⁇
  • a value of ⁇ is below a threshold T ⁇
  • ⁇ and ⁇ are calculated as follows
  • r xy is a sample correlation coefficient between x and y
  • s x is a standard deviation of x
  • s y is a standard deviation of y
  • a horizontal bar over a variable denotes a sample average of the variable
  • the producing FES includes producing a same electric stimulation signal to all electrodes receiving the electric stimulation signal.
  • the producing FES includes producing an electric stimulation signal with a frequency of approximately 30-200 Hz, including pulse durations of 100-300 ⁇ s.
  • the producing FES includes producing an electric stimulation signal lasting for a period of time in a range of 250 milliseconds to 1250 milliseconds.
  • the determining when the patient's glottis is expected to be closed is performed following receipt of a command input.
  • the receipt of the command input includes receipt of the command input from a processor analyzing a signal from a sensor configured to sense receipt of a command input from the patient.
  • the receipt of the command input from the patient includes receipt of a command input from the processor analyzing a nasal air signal from a patient's nasal air flow sensor.
  • the sensor configured to sense receipt of a command input from the patient includes at least one sensor selected from a group including an eye blink sensor, a microphone, an electromyography (EMG) electrode configured for sensing the patient's EMG activity of the neck muscles, a chest belt for monitoring respiration, and an electrophysiological sensor for sensing abdominal muscles.
  • EMG electromyography
  • the receipt of the command input includes receipt of a command input from a caregiver.
  • the adjusting the FES includes adjusting when to start the FES.
  • the adjusting when to start the FES includes determining an average duration of a patient's closing the glottis, adjusting to start the FES a short period of time prior to an end of the determining when a patient's glottis is expected to be closed.
  • the adjusting the FES includes adjusting a duration of the FES.
  • the adjusting the FES includes using feedback to adjust the FES.
  • the feedback includes at least one parameter selected from a group consisting of a value assigned to the patient's feedback, a value assigned to a medical practitioner' feedback, a value of air flow temperature during a cough which is assisted by the FES, a value of CO 2 concentration during a cough which is assisted by the FES, a value of electromyography (EMG) measured during a cough which is assisted by the FES, a value of PEF (Peak Expiratory Flow) of a cough which is assisted by the FES, a value of maximum nasal expiration during the cough which is assisted by the FES, a value of maximum volume of a sound of the cough which is assisted by the FES, and a value of maximum output of lung air of the cough which is assisted by the FES.
  • EMG electromyography
  • the adjusting the FES includes using machine learning to adjust the FES.
  • a method of providing Functional Electric Stimulation (FES) to assist coughing including detecting an intent to cough in a patient, detecting a time of glottis closure in the patient, providing FES to assist coughing delayed by a period of time following the glottis closure.
  • FES Functional Electric Stimulation
  • the detecting an intent to cough includes detecting a plateau in nasal air flow.
  • the detecting an intent to cough includes detecting a value of nasal air flow less than a threshold value lasting longer than 50 milliseconds.
  • the nasal air flow parameters for the detecting an intent to cough consists of a value of a slope of air flow data points during inspiration exceeding a threshold value.
  • the detecting the time of glottis closure in the patient includes detecting a time when nasal air flow transitions from inspiration to a minimum of air flow.
  • the invention further including measuring the patient's glottis closure duration over a plurality of breathing cycles by the patient which include glottis closure and coughing, determining a typical glottis closure duration for the patient, providing FES to the patient at a time delayed by the period of time following the glottis closure, the delay being less than the typical glottis closure duration for the patient.
  • a value for the typical glottis closure duration is determined by averaging glottis closure duration over the plurality of breathing cycles by the patient which included glottis closure and coughing.
  • the period of time is 20-100 milliseconds less than the typical glottis closure duration for the patient. According to some embodiments of the invention, the period of time is in a range of 10%-30% shorter than the typical glottis closure duration for the patient.
  • the period of time is adjusted to optimize the patient's cough.
  • a duration of the FES is adjusted to optimize the patient's cough.
  • optimizing the patient's cough is based on at least one parameter selected from a group consisting of a value assigned to the patient's feedback, a value assigned to a medical practitioner' feedback, a value of air flow temperature during a cough which is assisted by the FES, a value of CO 2 concentration during a cough which is assisted by the FES, a value of electromyography (EMG) measured during a cough which is assisted by the FES, a value of PEF (Peak Expiratory Flow) of a cough which is assisted by the FES, a value of maximum nasal expiration during the cough which is assisted by the FES, a value of maximum volume of a sound of the cough which is assisted by the FES, and a value of maximum output of lung air of the cough which is assisted by the FES.
  • EMG electromyography
  • a non-transitory computer-readable medium containing instructions for a method of assisted coughing as described herein.
  • Implementation of the method and/or system of embodiments of the invention can involve performing or completing selected tasks manually, automatically, or a combination thereof. Moreover, according to actual instrumentation and equipment of embodiments of the method and/or system of the invention, several selected tasks could be implemented by hardware, by software or by firmware or by a combination thereof using an operating system.
  • hardware for performing selected tasks according to embodiments of the invention could be implemented as a chip or a circuit.
  • selected tasks according to embodiments of the invention could be implemented as a plurality of software instructions being executed by a computer using any suitable operating system.
  • the software instructions are stored on a non-transitory computer readable storage media.
  • one or more tasks according to exemplary embodiments of method and/or system as described herein are performed by a data processor, such as a computing platform for executing a plurality of instructions.
  • the data processor includes a volatile memory for storing instructions and/or data and/or a non-volatile storage, for example, a magnetic hard-disk and/or removable media, for storing instructions and/or data.
  • a network connection is provided as well.
  • a display and/or a user input device such as a keyboard or mouse are optionally provided as well.
  • FIG. 1 is a simplified illustration of a system for gathering data from a patient according to an example embodiment of the invention
  • FIG. 2 depicts three graphs showing a microphone signal, nasal air flow and an electromyographic (EMG) signal of glottis and neck muscles as measured by the system of FIG. 1 ;
  • EMG electromyographic
  • FIG. 3 is a bar graph of a time difference between a beginning of a plateau in nasal air flow and glottis closure onset as observed by video;
  • FIG. 4 is a simplified illustration of a system for assisting coughing according to an example embodiment of the invention.
  • FIG. 5 depicts six graphs showing a stimulator signal, a microphone signal, a FES trigger signal, a nasal flow signal, a glottis and neck EMG signal and an abdomen EMG signal as measured by a system such as the system of FIG. 4 on a non-paralyzed subject;
  • FIGS. 6A, 6B and 6C are simplified illustrations of stimulation electrode arrangements on an abdomen of a subject according to example embodiments of the invention.
  • FIG. 7 depicts six graphs showing a stimulator signal, a microphone signal, a FES trigger signal, a nasal flow signal, a glottis and neck EMG signal and an abdomen EMG signal as measured by a system such as the system of FIG. 4 on a subject with tetraplegia, without stimulation and with stimulation delivered by two electrode pairs as illustrated in FIG. 6A ;
  • FIG. 8 depicts four graphs showing a stimulator signal, a microphone signal, a FES trigger signal and a nasal flow signal as measured by a system such as the system of FIG. 4 on a subject with tetraplegia, without stimulation and with stimulation delivered by four electrode pairs as illustrated in FIG. 6B ;
  • FIG. 9A is a simplified block diagram illustration of a system for assisted coughing according to an example embodiment of the invention.
  • FIG. 9B is a simplified block diagram illustration of a system for assisted coughing according to an example embodiment of the invention.
  • FIG. 10A is a simplified flow chart diagram of a method for assisted coughing according to an example embodiment of the invention.
  • FIG. 10B is a simplified flow chart diagram of a method for assisted coughing according to another example embodiment of the invention.
  • FIG. 10C is a simplified flow chart diagram of a method for assisted coughing according to yet another example embodiment of the invention.
  • FIG. 10D is a simplified flow chart diagram of a method for providing Functional Electric Stimulation (FES) to assist coughing according to still another example embodiment of the invention.
  • FES Functional Electric Stimulation
  • the present invention in some embodiments thereof, relates to methods and systems for using nasal airflow to activate Functional Electrical Stimulation (FES) of abdominal muscles to assist coughing.
  • FES Functional Electrical Stimulation
  • FES of abdominal muscles can be useful, assisting the patients in producing an effective cough.
  • the inventors presume that the results of applying FES to abdominal muscles, as mentioned above with reference to Professor Catz, have not been positive because activation of the FES was not synchronized with onset of patient glottis closure in order to evoke an effective cough.
  • An aspect of some embodiments of the invention relates to synchronizing FES of a cough and a patient's breathing and/or residual cough and/or determination of a closed glottis.
  • An aspect of some embodiments of the invention relates to a duration of FES applied to the patient.
  • the FES is shorter than any apparently described in the references mentioned above, in order to produce a short, explosive, cough rather than a long, forced, expiration of air.
  • An aspect of some embodiments of the invention relates to smart coughing, in which a patient's needs and/or commands are used to modify parameters used in synchronizing the cough and in producing the cough.
  • An aspect of some embodiments of the invention relates to a method for providing Functional Electric Stimulation (FES) to assist coughing by detecting an intent to cough in a patient, detecting a time of glottis closure in the patient, and providing FES to assist coughing, optionally at a specific time following the glottis closure.
  • FES Functional Electric Stimulation
  • An aspect of some embodiments of the invention relates to respiratory rehabilitation.
  • a system of assisted coughing as described herein may be used to rehabilitate respiratory action of patients with a weak respiratory action. Use of the system potentially rehabilitates respiratory action in patients.
  • the inventors have developed a method providing effective synchronization between FES triggering and a patient's breathing and/or residual cough.
  • example methods of which are described below are used to integrate a nasal-air-controlled trigger to activate the FES.
  • the synchronization is optionally made with sub-second precision.
  • a patient's nasal air flow is monitored, and the patient can optionally provide a signal to a system to produce FES and cause a cough.
  • sensors for measuring the nasal airflow are considered potentially less intrusive than measurement systems measuring parameters at the mouth, and are potentially more reliable.
  • the signal may be any signal detectable by a system such as described in above-mentioned Published PCT Patent Application WO 2010/122560 of Sobel et al.
  • the signal detection can optionally generate an instruction for a FES controller to produce FES to the abdomen, in which case the patient has initiated a command to cause a cough.
  • a non-limiting example of such an instruction may optionally be two consecutive sniffs (nasal air signals) by the patient, optionally causing production of a command to cause a cough and/or to assist a natural cough.
  • the signal detection optionally generates an instruction for activating a FES controller to produce FES to the abdomen, in which case the patient has optionally initiated a command to cause a cough.
  • the signal detection can optionally detect signs of an oncoming cough, which might be a weak cough, and generate an instruction for a FES controller to produce FES to the abdomen, in which case the weak cough is augmented by the FES.
  • the signal detection can optionally cause the above-mentioned detection system to start a period of attempting to determine when a cough starts. The patient then initiates a cough, the detection system determines an oncoming cough, and assists in the coughing by initiating the FES to the abdomen.
  • Such a setup can be useful for patients which cannot cough effectively, and provide a command which causes the example embodiment to assist their attempt at coughing.
  • various methods of determining a cough based on nasal air signals are used, examples of which are described below.
  • FES signals are used to stimulate coughing, examples of which are described below.
  • different electrode arrangements are used to provide FES signals to the patient's abdomen, examples of which are described below.
  • a system which enables computerized control of the FES and incorporates nasal air controller technology for FES triggering.
  • software is used to measure the nasal air pressure, and to converts the pressure into electrical signals, which in turn, will be used as a trigger to activate the FES, as illustrated in FIG. 1 and described with reference to FIG. 1 .
  • the inspired air controller technology and FES were integrated using, by way of a non-limiting example, an electrician microcontroller device.
  • the firmware microcontroller is an open-source electronics prototyping platform based on flexible, easy-to-use hardware and software, potentially providing a low cost system.
  • the electrician microcontroller can receive analog inputs from pressure sensors and can be programmed to trigger the FES.
  • the system operates in a self-activation mode, with a manual standby button.
  • FIG. 1 is a simplified illustration of a system 100 for gathering data from a patient 102 according to an example embodiment of the invention.
  • FIG. 1 depicts a patient 102 with a cannula 104 for providing nasal air to one or more sensors 106 .
  • the sensors 106 optionally sense nasal air flow.
  • the sensors 106 optionally sense air pressure.
  • the sensors 106 provide an output signal 108 , which in some embodiments—as described above with reference to the PC microcontroller—may be analog, and in some embodiments may be digital.
  • the output signal 108 is optionally provided to a microcontroller 110 , such as the above-mentioned PC, or an AD Instruments Power Lab unit.
  • the microcontroller 110 optionally provides output signals 112 to a computer 114 , optionally for further processing and/or storage.
  • the microcontroller 110 optionally accepts input from additional sources of signals which may optionally also serve, alone or in combination with each other and/or with the nasal air signals, to determine an oncoming cough or a patient command.
  • a microphone 116 optionally provides an input signal to the microcontroller 110 .
  • electromyography (EMG) electrodes 118 may optionally be connected to the patient's throat, and provide signals 120 to an optional electrophysiological signal amplifier 122 , which optionally provides an output 124 to the microcontroller 110 .
  • EMG electromyography
  • a cough reflex processed by the medulla, is preceded by a series of events, typically in the following order: (I) air inspiration; (II) tight closure of the glottis to trap the air within the lungs; (III) forceful contraction of abdominal muscles and accessory expiratory muscles; and (IV) a sudden opening of the glottis and outward explosion of the air under pressure.
  • FES is used to assist the contraction of the abdominal muscles.
  • the contraction of the abdominal muscles optionally comes at a precise, correct timing after closure of the glottis.
  • glottis closure is optionally evaluated by glottis electrical activity and electrical activity of other neck muscles during a cough using electromyography (EMG).
  • EMG electromyography
  • a setup for measuring nasal respiration during a cough is used concurrently with measuring EMG activity of the neck muscles as illustrated in FIG. 1 .
  • a setup for measuring nasal respiration during a cough is used concurrently with monitoring a chest belt for monitoring respiration (not shown).
  • FIG. 2 depicts three graphs 210 220 230 showing a microphone signal 212 , nasal air flow 222 and an electromyographic (EMG) signal 232 of glottis and neck muscles as measured by the system 100 of FIG. 1 .
  • EMG electromyographic
  • the graphs 210 220 230 all share a common X-axis 202 depicting time.
  • FIG. 2 depicts a typical nasal respiratory pattern during coughing. It is noted that negative flow corresponds to inspiration 224 while a positive flow indicates expiration 223 .
  • the nasal air flow 222 in the middle graph 220 depicts a nasal air flow trace and the lower graph 230 depicts EMG activity. It is noted that in the present application some of the Figures showing nasal air flow traces, such as the middle graph 220 , show expiration as a trace toward a top of the graph, while some of the Figures, such as FIGS. 5, 7 and 8 , show expiration as a trace toward a bottom of the graph. A person skilled in the art can differentiate between the two types of traces based on the direction of sections indicates as expiration, inspiration, and expiration cough.
  • point 226 is considered by the inventors to potentially indicate glottis closure.
  • EMG activity 234 is depicted in the lower graph 230 at approximately the same time as glottis closure in the middle graph 220 .
  • an endoscopic video camera was added (not shown in FIG. 1 ), synchronized with the nasal air flow 222 measurements, the microphone signal 212 and the EMG signal 232 during coughing.
  • the addition of the endoscopic video camera provided a reproducible time difference measurement between glottis closure and the nasal respiration plateau.
  • FIG. 3 is a bar graph of a time difference between a beginning of a plateau in nasal air flow and glottis closure onset as observed by video.
  • FIG. 3 depicts an X-axis 301 indexing 7 of the above 7 non-paralyzed subjects, and a Y-axis 302 showing the time difference between the beginning of the plateau in nasal air flow and glottis closure onset as observed by video for the 7 subjects.
  • a mean closure time of the glottis was found to be approximately 200 milliseconds.
  • the mean closure time of the glottis is also supported by scientific literature, which supports the findings.
  • a beginning of the plateau after a sharp drop in inspiration air flow, as depicted in FIG. 2 is taken as a moment of closure of the glottis.
  • the FES is activated exactly at the beginning of the glottis closure.
  • software for detection of a respiratory feature which indicates glottis closure was developed, which continuously samples a nasal air flow trace.
  • a trigger for providing the FES is optionally activated when the software detects two consecutive features in the nasal air trace.
  • a first feature is an existence of a flat interval lasting approximately 50 ms.—a plateau—and a second feature is a negative slope in the preceding 50 ms.
  • the 50 ms flat interval is optionally detected by calculating a difference between a maximum and a minimum nasal air flow trace values over a sample interval.
  • the difference is sampled at short intervals and a ‘plateau’ is detected if the difference is smaller than a specific threshold.
  • all samples have to be within a specified window from a baseline.
  • the sampling rate of the difference is 1 kHz. In some embodiments the sampling rate ranges from 100 Hz to 10 kHz.
  • a straight line is calculated based on the first and the last samples of a slope test interval and a set of residual values is produced by subtracting the sampled signals from the straight line.
  • a slope is considered detected if a difference between a maximum residual value and a minimum residual value is smaller than a corresponding threshold.
  • a second method is used.
  • both the flat interval (plateau) and slope interval were each fitted to a straight line and two coefficients ( ⁇ and ⁇ ) were extracted using the following equations:
  • r xy is a sample correlation coefficient between x and y
  • s x is a standard deviation of x
  • s y is correspondingly the standard deviation of y
  • a horizontal bar over a variable means a sample average of that variable:
  • the FES is triggered if the ⁇ and the ⁇ coefficients, obtained from the equation above, are below a certain threshold.
  • An example embodiment of a system combining nasal air flow analysis and FES was tested on 10 non-paralyzed subjects. The subjects were asked to breathe normally through the mouth and to cough voluntarily, and the ability of the system to synchronize cough determination and FES activation at the time frame of coughing was tested.
  • FIG. 4 is a simplified illustration of a system 400 for assisting coughing according to an example embodiment of the invention.
  • FIG. 1 depicts a patient 402 with a cannula 404 for providing nasal air to one or more sensors 406 .
  • the sensors 406 optionally sense nasal air flow.
  • the sensors 406 optionally sense air pressure.
  • the sensors 406 provide an output signal 408 , which in some embodiments—as described above with reference to the PC microcontroller—may be analog, and in some embodiments may be digital.
  • the output signal 408 is optionally provided to a microcontroller 410 , such as the above-mentioned PC, and/or to a laboratory instrumentation unit 411 such as an AD Instruments Power Lab unit.
  • a microcontroller 410 such as the above-mentioned PC
  • a laboratory instrumentation unit 411 such as an AD Instruments Power Lab unit.
  • the laboratory instrumentation unit 411 optionally provides output signals 412 to a computer 414 , optionally for further processing and/or storage.
  • the laboratory instrumentation unit 411 optionally accepts input from additional sources of signals which may optionally also serve, alone or in combination with each other and/or with the nasal air signals, to determine an oncoming cough or a patient command.
  • a microphone 416 optionally provides an input signal to the laboratory instrumentation unit 411 .
  • one or more electromyography (EMG) throat electrodes 418 are optionally connected to the patient's 402 throat, and provide signals 420 to an optional electrophysiological signal amplifier 422 , which optionally provides an output 424 to the laboratory instrumentation unit 411 .
  • EMG electromyography
  • one or more electromyography (EMG) abdominal electrodes 419 are optionally connected to the patient's 402 body, and optionally provide signals 420 to an optional electrophysiological signal amplifier 422 , which optionally provides an output 424 to the laboratory instrumentation unit 411 .
  • EMG electromyography
  • FIG. 4 depicts the microcontroller 410 providing an output signal 409 , optionally to a FES controller 430 , such as an instruction to the FES controller 430 to generate one or more electric stimulation signals to electric stimulation electrodes 432 attached to the body of the patient 402 .
  • output of the controller 430 comprises of two leads: Pole1 and Pole2.
  • the FES controller 430 provides the same electric stimulation signals in parallel over any number of electrodes, such as one electrode pair, two electrode pairs, three electrode pairs, four electrode pairs, and more electrode pairs.
  • the electrodes 420 optionally collect EMG signals from the abdomen, and provide the EMG signals (not shown) to the electrophysiological signal amplifier 422 or to a separate electrophysiological signal amplifier (not shown), either of which optionally provide an output which may optionally be gathered by the computer 414 as described above with reference to the throat EMG signals 418 .
  • nasal respiration may be specific, per each individual, and dynamics of the soft palate (glottis) may change during measurements.
  • the nasal air flow analysis and FES system continuously measures the nasal air flow during coughing, optionally distinguishes between coughing and normal breathing, and activates the FES at an exact timing of glottis closure, as shown FIG. 5 and described below.
  • FIG. 5 depicts six graphs 510 520 530 540 550 560 showing a stimulator signal 512 , a microphone signal 522 , a FES trigger signal 532 , a nasal flow signal 542 , a glottis and neck EMG signal 552 and an abdomen EMG signal 562 as measured by a system such as the system 400 of FIG. 4 on a non-paralyzed subject.
  • FIG. 5 depicts six graphs 510 520 530 540 550 560 share a common X-axis 502 depicting time.
  • neck muscle activity starts earlier than glottis closure, as depicted in the nasal flow signal 542 .
  • the neck muscle activity starts earlier than glottis closure by 421 ⁇ 181 milliseconds.
  • abdominal muscle activity as depicted by the abdomen EMG signal 562 starts later than neck muscle activity as depicted by the glottis and neck EMG signal 552 , and occurs earlier than glottis closure by 182 ⁇ 163 milliseconds.
  • a cough is characterized by a large inspiratory nasal air flow peak.
  • the microcontroller 410 provided the FES controller 430 with an output signal 409 , by way of a non-limiting example with a pulse signal trigger at a frequency of 100 Hz for 500 ms, within a response time of 37 ⁇ 12 milliseconds.
  • the FES controller 430 produced a stimulator output as shown by the stimulator signal 512 in FIG. 5 .
  • the FES is applied for 500 ms, as described above, in some embodiments, a shorter FES signal is applied, for example 250 ms, and in some examples a longer FSE signal is applied, for example 1000 ms, or even 1250 ms.
  • stimulation can optionally be delivered at normal abdominal muscle activity timing for coughing for people with tetraplegia.
  • the system 400 of FIG. 4 was tested on a person with tetraplegia. Stimulation was delivered directly to the abdominal muscles using self-adhesive surface electrodes.
  • FIGS. 6A, 6B and 6C are simplified illustrations of stimulation electrode arrangements on an abdomen 602 of a subject according to example embodiments of the invention.
  • FIGS. 6A, 6B and 6C depict a simplified outline 602 indicating a general shape of a subject's abdomen, and a navel represented by a circle near the middle of the outline 602 .
  • FIG. 6A depicts a non-limiting example embodiment with two electrode pairs 604 a 604 b 605 a 605 b arranged on the abdomen 602 of the subject.
  • the first electrode pair 604 a 604 b optionally has two poles
  • the second electrode pair 605 a 605 b optionally has two poles.
  • the two separate electrode-pairs 604 a 604 b and 605 a 605 b are stimulated by two separate stimulation signals.
  • the two separate electrode-pairs 604 a 604 b and 605 a 605 b are stimulated in parallel by one stimulation signal, as during a first test described below.
  • stimulation was delivered by the FES controller 430 with one output channel feeding two separate electrode-pairs 604 a 604 b and 605 a 605 b in parallel, for a total of four electrodes arranged as illustrated in FIG. 6A .
  • FIG. 6B depicts a non-limiting example embodiment with four electrode pairs 606 a 606 b 607 a 607 b 608 a 608 b 609 a 609 b arranged in four separate electrode-pairs on the abdomen 602 of the subject.
  • the four separate electrode-pairs 606 a 606 b 607 a 607 b 608 a 608 b 609 a 609 b are stimulated by four (or less) separate stimulation signals.
  • the four separate electrode-pairs 606 a 606 b 607 a 607 b 608 a 608 b 609 a 609 b are stimulated by one stimulation signal, as during a second test described below.
  • a four separate electrode-pair configuration was tested, for a total of eight electrodes 606 a 606 b 607 a 607 b 608 a 608 b 609 a 609 b arranged in pairs, as illustrated in FIG. 6B .
  • Abdominal muscles were stimulated bilaterally, with two electrode pairs stimulating the rectus muscles of the abdomen, and two electrode pairs stimulating the lateral abdominal muscle group, that is the transverse muscles of abdomen, and abdominal external and internal muscles.
  • the electrode pairs are used with a first electrode of a pair being a positive electrode and a second electrode of the pair being a negative electrode.
  • FIG. 6C depicts a non-limiting example embodiment with two area electrodes 610 a 610 b arranged as an electrode-pair on the abdomen 602 of the subject.
  • the two area electrodes 610 a 610 b are stimulated by one stimulation signal.
  • only one FES output channel is used.
  • the one output channel may optionally be connected to all pairs of electrodes. In this configuration the FES system was found to be highly effective in eliciting cough.
  • the electrodes are implanted rather than attached to a patient's skin.
  • an external connection to the electrodes is provided to power the implanted electrodes.
  • power is provided to the electrodes through the skin, optionally by a contactless inductive power supply.
  • FIG. 7 and FIG. 8 below depict additional results of using the system of FIG. 4 , and demonstrate eliciting a highly effective cough.
  • FIG. 7 depicts six graphs 710 720 730 740 750 760 showing a stimulator signal 712 , a microphone signal 722 , a FES trigger signal 732 , a nasal flow signal 742 , a glottis and neck EMG signal 752 and an abdomen EMG signal 762 as measured by a system such as the system 400 of FIG. 4 on a subject with tetraplegia, without stimulation 770 and with stimulation 780 delivered by two electrode pairs as illustrated in FIG. 6A .
  • the six graphs 710 720 730 740 750 760 share a common X-axis 702 depicting time.
  • stimulation produced a stronger cough confirmed by a measured sound intensity as depicted by the microphone signal 722 , and by a ratio between an expiration depth 772 of a non-stimulated cough and an expiration depth 774 of a stimulated cough, as depicted by the nasal flow signal 742 .
  • FIG. 8 depicts four graphs 810 820 830 840 showing a stimulator signal 812 , a microphone signal 822 , a FES trigger signal 832 and a nasal flow signal 842 as measured by a system such as the system 400 of FIG. 4 on a subject with tetraplegia, without stimulation 870 and with stimulation 880 delivered by four electrode pairs as illustrated in FIG. 6B .
  • the four graphs 810 820 830 840 share a common X-axis 802 depicting time.
  • effectiveness of the stimulated cough was also assessed quantitatively by measuring a total volume of expiration after a natural cough, approximately 1 liter, and after a stimulated cough, approximately 3 liters.
  • parameters of the FES signal are optionally varied.
  • FES is delivered for a period of 1 second to two electrode pairs, at a frequency of 50 Hz, a constant current of 100 mA per electrode pair, and at a 200 ⁇ s pulse duration.
  • a subject to which the above FES was applied reported that it was hard for him to inhale after the stimulation.
  • FES is delivered for a period of 0.5 second to four electrode pairs, at a frequency of 100 Hz, a constant current of 250 mA for the four electrode pairs (62.5 mA per electrode pair), and at a 200 ⁇ s pulse duration (as depicted in FIG. 8 above).
  • the subject to which the above FES was applied reported that the stimulated cough was effective and did not cause any discomfort.
  • signal analysis is applied to the nasal air flow signal (such as the nasal flow signal 742 of FIG. 7 and the nasal flow signal 842 of FIG. 8 ).
  • the signal analysis optionally assists detecting when a patient intends to cough, and/or when to apply FES to assist the cough.
  • the signal analysis optionally detects parameters which relate to breathing and coughing.
  • Some non-limiting example parameters include:
  • a baseline of normal breathing is established using typical and/or average values and optionally measured deviations from the average values for a specific patient.
  • a study of breathing cycles which include coughing is established using typical and/or average values and optionally measured deviations from the average values for a specific patient.
  • the above parameter values are optionally collected for several normal breathing cycles, and/or optionally collected for several breathing cycles which include a cough, whether natural or FES-induced.
  • a difference between parameters typical for normal breathing and parameters for breathing which includes a cough optionally serve an automatic system to detect when a patient intends to cough, by analyzing the patient's breathing pattern.
  • the inventors have performed studies of glottis closure duration prior to a cough, and have measured a range of glottis closure durations from approximately 200 milliseconds to approximately 300 milliseconds.
  • the inventors have discovered that good coughing occurs when FES starts somewhat prior to the end of the period of glottis closure, for example approximately 30 milliseconds prior to the end of the period of glottis closure.
  • FES is caused to start in a range of 20-100 milliseconds prior to the end of the period of glottis closure.
  • FES is caused to start in a range of 10%-30% of the patient's glottis closure duration prior to the end of the period of glottis closure.
  • the glottis closure duration is measured per individual patient so that starting FES prior to end of glottis closure not accidentally start after end of glottis closure because of a large difference, for example in a range of 100-300 milliseconds, of glottis closure durations between patients.
  • good coughing is optionally determined by one or more of: a patient's providing a subjective assessment; a measure of air flow volume expired in a cough; and a measure of air flow velocity during a cough.
  • a training period is set up, where a patient coughs several times, e.g. 3 times or more, and an average duration of glottis closure is calculated for the patient.
  • a system Based on the average duration of glottis closure during the training period, a system optionally detects beginning of glottis closure, as described elsewhere herein, and starts FES prior to the end of the average period of glottis closure, for example approximately 30 milliseconds prior to the end of the average period of glottis closure.
  • a training period is set up, where a patient coughs several times, e.g. 3 times or more, and an average of several parameters are measured off the air flow signal.
  • the following non-limiting example parameters are optionally measured and optionally averaged:
  • the average values of the maximum of inspiration and of the value of the slope of inspiration air flow are optionally taken as representative of a patient's intent to cough.
  • the cough assisting system optionally detects intent to cough.
  • the average value of the duration of the glottis closure in the patient are optionally used to determine when to apply FES to the patient.
  • FES is optionally applied prior to an expected end of glottis closure, optionally based on the average value of the duration of the glottis closure in the patient.
  • training is performed continuously, and when a patient coughs an average duration of glottis closure is optionally adjusted to be a running average or an average of last N coughs.
  • a beginning time of glottis closure is detected or estimated when the nasal flow signal has a negative slope followed by an end of the negative slope at a minimum value.
  • the beginning time of glottis closure is optionally estimated as the time of reaching the minimum.
  • the time for starting to provide FES is determined relative to the detected beginning time of glottis closure.
  • the time for starting to provide FES is determined relative to the detected beginning time of glottis closure, plus a determined average period of glottis closure for a patient.
  • the time when to start FES is optionally adjusted for improving, or optimizing, remedient effect on a patient.
  • the optimization optionally occurs by adjusting when to start providing FES relative to a specific point in time.
  • the time when to start FES is optionally adjusted by a user, such as the patient or a medical practitioner, providing adjust instructions such as “earlier” or “later”, or by the user actually adjusting a number via numeric input or by rotating a knob or moving a real or virtual slider in a user interface.
  • the specific point in time is the time determined for the patient's glottis closure. In some embodiments the specific point in time is the time determined for the patient's glottis closure plus an average duration of the patient's glottis closure over a plurality of coughs. In some embodiments the specific point in time is the time when the patient activates a request signal for providing the FES.
  • adjusting when to start providing FES is performed by using machine learning to learn at what time starting to provide FES provides most benefit to the patient.
  • providing most benefit is optionally determined by measuring an output parameter based on a cough befitting from the FES, and optionally affecting the output parameter by adjusting when to start providing FES, optionally relative to the above-mentioned specific point in time.
  • a professional such as a medical practitioner, providing a feedback value
  • a value of a physiological parameter measured off the patient with a relation to breathing and/or coughing such as air flow temperature, CO 2 concentration (Capnography), electromyography (EMG);
  • a value of a measurable parameter such as PEF (Peak Expiratory Flow);
  • a value of a measurable parameter such as maximum nasal expiration during a cough
  • a value of a measurable parameter such as maximum volume of a sound of a cough, optionally as measured by a microphone
  • a value of a measurable parameter such as maximum output of lung air, optionally by coughing into a measuring device during training of a system providing FES.
  • FES Functional Electrical Stimulation
  • the duration of the FES is optionally adjusted for improving, or optimizing, remedient effect on a patient.
  • the optimization optionally occurs by adjusting the duration of the FES.
  • the duration of the FES is a fixed duration.
  • the duration of the FES is adjusted by a user, such as the patient or a medical practitioner, providing adjust instructions such as “longer” or “shorter”, or by the user actually adjusting a number via numeric input or by rotating a knob or moving a real or virtual slider in a user interface.
  • adjusting the duration of the FES is performed by using machine learning to learn what the duration of the FES provides most benefit to the patient.
  • providing most benefit is optionally determined by measuring an output parameter based on a cough befitting from the FES, and optionally affecting the output parameter by adjusting the duration of the FES.
  • a professional such as a medical practitioner, providing a feedback value
  • a value of a physiological parameter measured off the patient with a relation to breathing and/or coughing such as air flow temperature, CO 2 concentration (Capnography), electromyography (EMG);
  • a value of a measurable parameter such as PEF (Peak Expiratory Flow);
  • a value of a measurable parameter such as maximum nasal expiration during a cough
  • a value of a measurable parameter such as maximum volume of a sound of a cough, optionally as measured by a microphone
  • a value of a measurable parameter such as maximum output of lung air, optionally by coughing into a measuring device during training of a system providing FES.
  • FIG. 9A is a simplified block diagram illustration of a system 900 for assisted coughing according to an example embodiment of the invention.
  • FIG. 9A depicts:
  • a first sensor 902 for measuring a parameter which can indicate a closed glottis and producing a first output signal 904 ;
  • a processor 906 for receiving the first output signal 904 , determining the closed glottis and generating an instruction 908 for a Functional Electric Stimulation (FES) controller 910 based, at least in part, on the determining; and
  • FES Functional Electric Stimulation
  • the FES controller 910 configured for generating an electric stimulation signal.
  • the first sensor of FIG. 9A is a nasal air sensor configured for sensing the patient's nasal air flow.
  • FIG. 9B is a simplified block diagram illustration of a system 920 for assisted coughing according to an example embodiment of the invention.
  • FIG. 9B depicts:
  • a first sensor 922 for measuring a parameter which can indicate a closed glottis and producing a first output signal 924 ;
  • a processor 926 for receiving the first output signal 924 , a command input 932 , determining the closed glottis and generating an instruction 928 for a Functional Electric Stimulation (FES) controller 930 based, at least in part, on the determining; and
  • FES Functional Electric Stimulation
  • the FES controller 930 configured for generating an electric stimulation signal.
  • the first sensor of FIG. 9B is a nasal air sensor configured for sensing the patient's nasal air flow.
  • the command input of FIG. 9B is provided by a second sensor configured to accept the command input.
  • the second sensor may even be a button or similar actuator for enabling the determining of the closed glottis, so that potentially cough stimulation is not stimulated unless something or someone provides a command allowing such stimulation.
  • the second sensor is configured to accept the command input from a caregiver.
  • the second sensor is configured to accept the command input from a patient.
  • the second sensor is configured to accept the command input from a computer, optionally configured to stimulate assisted coughing according to some criterion, such as every period of time, or according to a sound of a patient breathing, such as a sound of loud breathing.
  • the patient command input is provided via the same nasal air flow sensor which is the first sensor.
  • EMG electromyography
  • an electrophysiological sensor for sensing abdominal muscles, optionally designed to sense an attempt at coughing by a patient, optionally providing a command enabling stimulated coughing upon a subsequent attempt at coughing by the patient.
  • FIG. 10A is a simplified flow chart diagram of a method for assisted coughing according to an example embodiment of the invention.
  • FIG. 10A depicts a method including:
  • FES Functional Electric Stimulation
  • FIG. 10B is a simplified flow chart diagram of a method for assisted coughing according to another example embodiment of the invention.
  • FIG. 10B depicts a method including:
  • FES Functional Electric Stimulation
  • the receiving of the command input includes receiving the command input from a processor analyzing a signal from a sensor configured to sense receipt of a command input from the patient.
  • the receiving of the command input includes receiving the command input from a processor analyzing a nasal air signal from a patient's nasal air flow sensor.
  • EMG electromyography
  • an electrophysiological sensor for sensing abdominal muscles.
  • the receiving of the command input includes receiving the command input from a caregiver, possibly by the caregiver providing an input to a computerized system, and/or even by the caregiver pressing a button.
  • some parameters used by a system for assisted coughing are optionally set by a user. Some non-limiting examples of such parameters will be listed below.
  • a caregiver such as a nurse or a physician, optionally sets the parameters.
  • a patient optionally sets the parameters.
  • a method for input from the patient may optionally be based upon the method described in above-mentioned PCT Patent Application WO 2010/122560 of Sobel et al, which describes a method of receiving input from a user, comprising measuring a nasal air parameter and generating an instruction for one or both of a device and controller based on said measurement.
  • setting the parameters is performed by navigating a menu system, optionally using the system of described in above-mentioned PCT Patent Application WO 2010/122560 of Sobel et al.
  • setting the parameters is performed by direct input of a set of commands, without navigating a menu.
  • a non-limiting list of adjustable parameters assisting coughing includes:
  • a desired coughing regime such as a specific times per hour, appropriate for a patient, optionally according to a specific medical condition.
  • Some aspects of smart coughing assistance include embodiments which monitor a patient's breathing, optionally detecting sonorous respiration, and providing automatic coughing assistance.
  • Some aspects of smart coughing assistance include embodiments which monitor a patient's breathing, optionally detecting sonorous respiration, and providing feedback to a patient and/or a caregiver that coughing assistance may be desirable.
  • Some aspects of smart coughing assistance include embodiments which maintain a specific regime of coughing, such as setting a number of coughs per unit of time.
  • the coughs may be automatically generated and/or suggested to a patient and/or caregiver by providing an alert.
  • FIG. 10C is a simplified flow chart diagram of a method for assisted coughing according to yet another example embodiment of the invention.
  • FIG. 10C depicts a method including:
  • determining whether the command input corresponds to a command for cough assistance or a command to set parameters in a cough assistance system ( 1022 );
  • FIG. 10D is a simplified flow chart diagram of a method for providing Functional Electric Stimulation (FES) to assist coughing according to still another example embodiment of the invention.
  • FES Functional Electric Stimulation
  • FIG. 10D depicts a method including:
  • a system of assisted coughing as described herein is optionally used to rehabilitate respiratory action of patients with a weak respiratory action. Use of the system potentially rehabilitates and potentially improves respiratory action in patients.
  • nasal air flow sensor It is expected that during the life of a patent maturing from this application many relevant nasal air flow sensors may be developed and the scope of the term nasal air flow sensor is intended to include all such new technologies a priori.
  • EMG sensor It is expected that during the life of a patent maturing from this application many relevant EMG sensors may be developed and the scope of the term EMG sensor is intended to include all such new technologies a priori.
  • compositions, method or structure may include additional ingredients, steps and/or parts, but only if the additional ingredients, steps and/or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.
  • a unit or “at least one unit” may include a plurality of units, including combinations thereof.
  • range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible sub-ranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed sub-ranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.
  • a numerical range is indicated herein, it is meant to include any cited numeral (fractional or integral) within the indicated range.
  • the phrases “ranging/ranges between” a first indicate number and a second indicate number and “ranging/ranges from” a first indicate number “to” a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numerals therebetween.
  • method refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacological, biological, biochemical and medical arts.

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JP6960905B2 (ja) * 2015-08-26 2021-11-05 コーニンクレッカ フィリップス エヌ ヴェKoninklijke Philips N.V. 機械的な送排気
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US10786681B2 (en) 2017-02-07 2020-09-29 Yaron Ilan Closed loop organ stimulation
CN108042133A (zh) * 2017-11-30 2018-05-18 北京航空航天大学 一种基于呼吸肌电信号智能分析的痰液淤积报警系统
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